WO2021128784A1 - 防移位支架及其制造方法 - Google Patents

防移位支架及其制造方法 Download PDF

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Publication number
WO2021128784A1
WO2021128784A1 PCT/CN2020/098605 CN2020098605W WO2021128784A1 WO 2021128784 A1 WO2021128784 A1 WO 2021128784A1 CN 2020098605 W CN2020098605 W CN 2020098605W WO 2021128784 A1 WO2021128784 A1 WO 2021128784A1
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WO
WIPO (PCT)
Prior art keywords
section
displacement
frame
growth space
dropping
Prior art date
Application number
PCT/CN2020/098605
Other languages
English (en)
French (fr)
Inventor
郭金和
陆建
朱光宇
韦建宇
沈正华
冯明浩
李玉茜
Original Assignee
南微医学科技股份有限公司
东南大学附属中大医院
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Application filed by 南微医学科技股份有限公司, 东南大学附属中大医院 filed Critical 南微医学科技股份有限公司
Publication of WO2021128784A1 publication Critical patent/WO2021128784A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/852—Two or more distinct overlapping stents

Definitions

  • This application relates to the technical field of medical devices, and in particular to an anti-displacement stent and a manufacturing method thereof.
  • the lumen of the human body (such as the esophagus or intestine) causes stenosis or obstruction and other diseases due to various reasons and pathological changes.
  • the current common treatment method is to implant a stent in the stenosis or obstruction to ensure the corresponding part of the lumen Patency.
  • the purpose of the present application includes, for example, to provide an anti-displacement stent, which can improve the problem of poor anti-displacement effect of the anti-displacement stent in the prior art.
  • the purpose of the present application also includes providing a method for manufacturing an anti-displacement stent, which is used for manufacturing the above-mentioned anti-displacement stent.
  • the embodiment of the present application provides an anti-displacement stent, which includes a body and a bare frame located outside the body; the bare frame includes an anti-drop part and a connecting part connected to one end of the anti-drop part;
  • the connecting portion is connected to the main body, the anti-dropping portion is configured to form a growth space with the main body, and the end of the anti-dropping portion away from the connecting portion is configured to form a growth space with the main body.
  • a space communicating opening; the anti-dropping part has a plurality of anti-dropping holes penetrating and communicating with the growth space, so that the tissue can enter the growth space through the anti-dropping holes.
  • the anti-dropping part is spaced apart from the body to form the growth space.
  • the body has a flexible portion, the anti-dropping portion is located outside the flexible portion, and the flexible portion is configured to deform, so that the growth is formed between the flexible portion and the anti-dropping portion. space.
  • the anti-dropping part has a ring shape, and the anti-dropping part is sleeved outside the body.
  • connection portion includes a plurality of sub-connection portions, and the plurality of sub-connection portions are sequentially arranged at one end of the anti-fall-off portion along the circumferential direction of the anti-fall-off portion.
  • a plurality of the anti-drop holes are distributed in a matrix to form a grid structure.
  • the anti-dropping portion is a mesh structure made by braiding metal wires, and the anti-dropping holes are mesh holes of the mesh structure.
  • the body includes a middle section and two cup mouth sections, the two cup mouth sections are respectively disposed at two ends of the middle section, and the radial size of the cup mouth section is larger than that of the middle section The radial dimension; the bare frame is located outside the cup mouth section.
  • the connecting portion is connected to the intermediate section.
  • the connecting portion and the middle section are spaced apart; the anti-displacement bracket further includes a first connecting line, and the connecting section is fixedly connected to the middle section through the first connecting line.
  • the anti-displacement stent further includes a first covering film disposed outside the connecting portion and the middle section, and two ends of the first covering film are respectively connected to the connecting portion and the middle section. Fixed connection.
  • the cup mouth section includes a large-diameter section, a connecting section, and a small-diameter section.
  • the radial size of the large-diameter section is larger than the radial size of the middle section; both ends of the connecting section are connected to the The large-diameter section is fixedly connected with the small-diameter section, and the small-diameter section is connected with the middle section; the bare frame extends from the large-diameter section to the small-diameter section.
  • the growth space includes a first growth space; the bare frame and the large diameter section are configured to form the first growth space.
  • the growth space further includes a second growth space; the bare frame and the connection section are spaced apart to form the second growth space between the bare frame and the connection section.
  • the intermediate section includes a plurality of first frame bodies arranged at intervals, and adjacent first frame bodies are connected by a connecting structure.
  • connection structure includes a second connection line, and two adjacent first frames are connected by the second connection line.
  • the intermediate section further includes a second covering film disposed on the connecting structure and the plurality of first frames.
  • the cup mouth section includes a second frame body and a third covering film arranged on the second frame body, and the bare frame is located outside the second frame body.
  • the anti-displacement bracket further includes skirts arranged at both ends of the body.
  • the anti-displacement stent further includes a particle capsule fixed on the body, and the particle capsule is configured to be filled with iodine particles.
  • the anti-displacement bracket further includes a first recovery rope and a second recovery rope;
  • the first recovery rope is provided on the body and is configured to pull the body under the action of an external force to change the The outer diameter of the body;
  • the second recovery rope is provided at an end of the anti-dropping portion away from the connecting portion, and is configured to pull the anti-dropping portion under the action of an external force to change the anti-dropping portion Outer diameter.
  • the embodiment of the present application also provides a method for manufacturing the anti-displacement bracket.
  • This method is used to manufacture the above-mentioned anti-displacement bracket.
  • the manufacturing method of the anti-displacement stent includes: arranging the anti-falling part of the bare frame outside the body, and connecting the connecting part of the bare frame with the body.
  • the step of disposing the anti-drop part of the bare frame outside the body, and connecting the connecting part of the bare frame with the body includes:
  • the anti-dropping part is sleeved on the cup mouth section of the body; the connecting part and the end of the cup mouth section are simultaneously connected with the middle section of the body by using a first connecting line; The area from the connecting part to the middle section is covered with a film.
  • the beneficial effects of the anti-displacement bracket and the manufacturing method of the embodiment of the present application include, for example:
  • the embodiment of the present application provides an anti-displacement stent, which includes a body and a bare frame arranged outside the body.
  • the bare frame includes an anti-dropping part and a connecting part connected to one end of the anti-dropping part, and the connecting part is connected with the main body, thereby connecting the bare frame to the main body.
  • the anti-dropping part is configured to form a growth space with the body, and the anti-dropping part is provided with a plurality of anti-dropping holes connected to the growth space.
  • the tissues of the human body lumen pass through the prevention
  • the hole enters the growth space and grows in the growth space to fix the anti-displacement stent and prevent the stent from shifting.
  • the connecting part is arranged at one end of the anti-falling part, the end of the anti-falling part away from the connecting part is connected to the growth space.
  • the opening of the device can obtain a larger growth space, and the anti-dropping effect is better.
  • the embodiment of the present application also provides a method for manufacturing the anti-shift bracket, which is used to manufacture the above-mentioned anti-shift bracket.
  • FIG. 1 is a schematic diagram of the overall structure of the anti-displacement bracket provided by an embodiment of the application from a first perspective;
  • Figure 2 is an enlarged schematic diagram of the partial structure at II in Figure 1;
  • FIG. 3 is a schematic diagram of a partial structure of the anti-displacement bracket provided by an embodiment of the application from a second perspective;
  • FIG. 4 is a partial structural diagram of another anti-displacement bracket provided by an embodiment of the application.
  • FIG. 5 is a schematic diagram of a cross-sectional structure at the mouth section of the anti-displacement bracket provided by an embodiment of the application;
  • FIG. 6 is a schematic diagram of a partial structure of the anti-displacement bracket provided by an embodiment of the application from a third perspective;
  • FIG. 7 is a schematic diagram of a cross-sectional structure of a particle capsule in an anti-displacement stent provided by an embodiment of the application.
  • Icon 10-anti-displacement bracket; 100-body; 110-cup opening section; 111-second frame body; 112-third covering film; 113-large diameter section; 114-connecting section; 115-small diameter section; 116 -Second sub-connecting part; 120-Middle section; 121-First frame body; 122-Second connecting line; 123-Second covering film; 130-Skirt; 200-Bare frame; 210-Connecting part; 211- The first sub-connection part; 220- the anti-falling part; 221- the anti-falling hole; 222- the first anti-falling section; 223- the second anti-falling section; 230- the first connecting line; 240- the first film; 310- First recovery rope; 320-second recovery rope; 330-particle capsule; 410-first growth space; 420-second growth space.
  • FIG. 1 is a schematic diagram of the overall structure of the anti-displacement bracket 10 provided by this embodiment from a first perspective
  • FIG. 2 is an enlarged schematic diagram of the partial structure at II in FIG. 1.
  • This embodiment provides an anti-displacement support 10, which includes a main body 100 and a bare frame 200 disposed outside the main body 100.
  • the bare frame 200 includes an anti-dropping portion 220 and a connecting portion 210 connected to one end of the anti-dropping portion 220.
  • the connecting portion 210 is connected to the main body 100 to connect the bare frame 200 to the main body 100.
  • the anti-dropping portion 220 is configured to form a growth space with the main body 100, and a plurality of anti-dropping holes 221 communicating with the growth space are formed on the anti-dropping portion 220. Therefore, when the anti-displacement stent 10 is implanted in the body cavity (such as the esophagus or intestine) After the tract, etc.), the tissue of the human lumen (for example, if the stent is extended into the human esophagus, the tissue is the tissue at the inner wall of the human esophagus) will contact the anti-drop part 220, and part of the tissue will pass through the anti-drop hole 221 Enter the growth space and grow in the growth space to fix the anti-displacement stent 10 for positioning and prevent the stent from shifting.
  • the body cavity such as the esophagus or intestine
  • the tissue of the human lumen for example, if the stent is extended into the human esophagus, the tissue is the tissue
  • the connecting portion 210 is provided at one end of the anti-dropping portion 220, only one end of the bare frame 200 is connected to the body 100 , The other end forms a free end, and the end of the anti-dropping portion 220 away from the connecting portion 210 forms an opening communicating with the growth space, so that a larger growth space can be obtained and the anti-dropping effect is better.
  • the body 100 includes a middle section 120 and two cup opening sections 110, and the two cup opening sections 110 are a first cup opening section and a second cup opening section, respectively.
  • the middle section 120, the first cup mouth section and the second cup mouth section are all round pipes.
  • the first cup mouth section and the second cup mouth section are respectively arranged at both ends of the middle section 120 in the axial direction.
  • the first cup mouth section and The radial dimension of the second cup mouth section is larger than the radial dimension of the middle section 120, so that the dumbbell-shaped body 100 is formed.
  • the length of the cup section 110 is a, 14mm ⁇ a ⁇ 16mm, and the length between the first cup section and the second cup section is specifically set according to the size of the lesion.
  • the first cup The length between the mouth section and the second cup mouth section is b, and 40mm ⁇ b ⁇ 150mm.
  • the cup mouth section 110 includes a second frame body 111 and a third film 112 covering the second frame body 111, so the shape feature of the second frame body 111 is the shape feature of the cup mouth section 110 .
  • the second frame 111 is a net-shaped cylinder woven with a single nickel-titanium wire.
  • the second frame 111 is coated with a film to form a third coating 112, thereby connecting the net on the second frame 111
  • the grid holes are closed to prevent the tissue from entering the anti-displacement stent 10 through the grid holes on the second frame body 111 after the anti-displacement stent 10 is put into the human body cavity.
  • the method of forming the third coating 112 can optionally be achieved by immersing the second frame 111 in liquid silica gel. After the liquid material covers all the mesh holes, the second frame 111 is taken out, and the coating is formed after cooling. There is a second frame 111 with a third film 112.
  • the bare frame 200 includes an anti-dropping portion 220 and a connecting portion 210 connected to one end of the anti-dropping portion 220.
  • the connecting portion 210 is connected to the main body 100 so as to connect the anti-dropping portion 220 to the main body 100.
  • the anti-dropping portion 220 is located outside the cup mouth section 110
  • the connecting portion 210 is connected to the end of the middle section 120
  • the end of the anti-dropping portion 220 away from the connecting portion 210 forms a free end.
  • the number of bare frames 200 is two, and the two bare frames 200 are respectively arranged outside the first cup opening section and the second cup opening section, and the connecting parts 210 of the two bare frames 200 are respectively axially connected to the middle section 120.
  • a growth space is formed between the anti-dropping portion 220 and the cup mouth section 110, and a plurality of anti-dropping holes 221 connected to the growth space are provided on the anti-dropping portion 220. Since the second frame body 111 constituting the cup mouth section 110 is covered with the third covering film 112, the tissue entering the first growth space 410 from the anti-dropping hole 221 cannot pass through the second covering film 112 due to the blocking of the third covering film 112. The frame body 111 continues to grow into the inside of the cup mouth section 110, thereby avoiding re-narrowing, and at the same time ensuring that the anti-displacement stent 10 can be recovered smoothly after the diseased part of the human lumen is cured.
  • the cup opening section 110 of the anti-displacement bracket 10 forms a double-layer structure, and the middle section 120 is a single-layer structure. Since the length of the cup opening section 110 is small, the opening section 110 is bare. After the frame 200 is arranged outside the cup mouth section 110, not only a good anti-displacement effect can be obtained, but also the anti-displacement stent 10 has a small effect on the tissues of the narrow part of the human lumen.
  • This structure can exert the anti-displacement function while avoiding the impact on the overall mechanical properties of the anti-displacement stent 10, thereby avoiding the problem of tissue necrosis and perforation due to excessive support force of the stent compressing the tissue in the narrow part of the lumen . It is understandable that in other embodiments, the position of the bare frame 200 can also be specifically set according to requirements.
  • the bare frame 200 is ring-shaped as a whole, that is, the anti-dropping portion 220 and the connecting portion 210 are both ring-shaped, and the anti-dropping portion 220 is sleeved on the cup mouth section 110, so that the anti-dropping portion 220 is away from one end of the connecting portion 210
  • a ring-shaped growth space is formed between the cup opening section 110 and the tissue can grow uniformly into the growth space along the circumference of the cup opening section 110, and the anti-dropping effect is better.
  • the multiple anti-drop holes 221 on the bare frame 200 are distributed in a matrix, thereby forming a grid structure, so that the tissue can evenly enter the first growth space 410 through the anti-drop holes 221.
  • the bare frame 200 is a mesh structure made of metal wire weaving, that is, the anti-dropping portion 220 is a mesh structure made of metal wire weaving, and the anti-dropping hole 221 is one of the adjacent metal wires on the mesh structure. Grid holes formed between. It should be noted that in this embodiment, the anti-drop hole 221 is a diamond-shaped mesh hole.
  • the shape of the anti-drop hole 221 can also be specifically set according to requirements, for example, the anti-drop hole 221 It is only required to be set in a circular shape, a long strip shape, a triangle shape, etc., and the tissue can enter the growth space through the anti-fall hole 221.
  • the bare frame 200 is made by weaving a single metal wire
  • the connecting part 210 is a plurality of protruding grids formed by the metal wire at the end of the bare frame 200, and each protruding grid forms a sub-connection part.
  • the sub-connection part is a first sub-connection part 211, and a plurality of first sub-connection parts 211 are sequentially arranged at one end of the anti-fall-off part 220 along the circumferential direction of the anti-fall-off part 220.
  • the material of the metal wire is Nitinol. Understandably, in other embodiments, other materials may be selected to make the bare frame 200 according to requirements.
  • FIG. 3 is a schematic diagram of a partial structure of the anti-displacement bracket 10 provided by this embodiment from a second perspective.
  • the second frame body 111 is a mesh structure woven by a single nickel-titanium wire
  • the end of the mesh structure is also formed with a plurality of protruding grids, and each protruding grid forms one
  • the sub-connection part is the second sub-connection part 116.
  • the anti-displacement bracket 10 further includes a first connecting wire 230, and the connecting portion 210 and the middle section 120 are connected by the first connecting wire 230.
  • the second sub-connection portion 116 and the first sub-connection portion 211 are arranged correspondingly, that is, the grid forming the first sub-connection portion 211 overlaps the grid forming the second sub-connection portion 116, and the first connection line 230
  • the first connecting wire 230 passes through the middle section 120 and simultaneously bypasses the first sub-connection portion 211 and the second sub-connection portion 116, and then passes through the middle section 120.
  • the connecting wires 230 are alternately wound around the middle section 120 and the overlapping positions of the first and second sub-connection parts 211 and 116 along the circumference of the main body 100, thereby connecting the bare frame 200 and the cup mouth section 110 with the middle section 120.
  • the first connecting wire 230 is a flexible wire, so that the connection is in a soft state, so that the anti-displacement stent 10 can better comply with the peristalsis of the human body lumen.
  • the first sub-connection portion 211 and the second sub-connection portion 116 are arranged in a one-to-one correspondence, and each second sub-connection portion 116 is arranged to overlap the corresponding first sub-connection portion 211. Further, the first connecting wire 230 is arranged to bypass each of the first connecting portion 210 and the second sub-connecting portion 116, so that the end of the bare frame 200 is wrapped by the first connecting wire 230, so as to prevent the end of the bare frame 200 from stabs or damages the tissue. Damage to the human body.
  • the anti-displacement stent 10 further includes a first covering film 240 disposed outside the connecting portion 210 and the middle section 120, and two ends of the covering film are fixedly connected to the connecting portion 210 and the middle section 120, respectively.
  • the first covering film 240 is provided to seal the hole created by the back and forth of the first connecting wire 230 to prevent the tissue from growing into the anti-displacement stent 10 through the hole.
  • the first covering film 240 extends to cover the grid forming the first sub-connection part 211, so the end of the bare frame 200 close to the end of the middle section 120 is covered by the first covering film 240, which further prevents the end of the bare frame 200 from puncturing tissue or Cause damage to the human body.
  • the method of forming the first coating film 240 can refer to the method of forming the third coating film 112 described above.
  • the first connecting rope is set to surround the first sub-connecting parts 211 at intervals.
  • FIG. 5 is a schematic cross-sectional structure diagram of the cup mouth section 110 of the anti-displacement bracket 10 provided by this embodiment, and only the bare frame 200 is cut in the cross-sectional view.
  • the second frame 111 includes a large-diameter section 113, a connecting section 114, and a small-diameter section 115 arranged in sequence.
  • the large-diameter section 113, the connecting section 114, and the small-diameter section 115 are passed through nickel-titanium metal wires. One-piece knitting.
  • the second sub-connecting portion 116 of the second frame 111 is formed at an end of the small-diameter section 115 away from the large-diameter section 113, and both ends of the connecting section 114 are fixedly connected to the large-diameter section 113 and the small-diameter section 115, respectively.
  • Both the large-diameter section 113 and the small-diameter section 115 are cylindrical structures.
  • the radial size of the large-diameter section 113 is larger than the radial size of the small-diameter section 115.
  • the radial dimension of the small-diameter section 115 is the same as the radial dimension of the middle section 120, and the radial dimension of the large-diameter section 113 is larger than the radial dimension of the middle section 120.
  • the bare frame 200 is sleeved outside the cup mouth section 110, and the end of the bare frame 200 away from the connecting portion 210 is located outside the large diameter section 113.
  • the connecting portion 210 of the bare frame 200 extends in the axial direction to cover the connecting section 114 and is located at the small diameter section 115.
  • the second sub-connection part 116 overlaps. Further, the bare frame 200 and the connecting section 114 are spaced apart, thereby forming a gap between the bare frame 200 and the connecting section 114.
  • the anti-dropping portion 220 includes a first anti-dropping section 222 and a second anti-dropping section 223 that are connected to each other.
  • the first anti-drop section 222 is wrapped around the large diameter section 113, and the growth space includes a first growth space 410 formed between the first anti-drop section 222 and the large diameter section 113. Since the cup mouth section 110 is made by covering the third film 112 on the second frame body 111 woven by a single nickel-titanium wire, the large-diameter section 113 can not only support the narrow part of the body lumen, but also has A certain degree of flexibility forms the flexible part of the body 100.
  • the tissue passes through the anti-dropping hole 221 and grows to the large diameter section 113, the tissue resists the large diameter section 113, causing the large diameter section 113 to slightly deform, so that the large diameter section 113 is slightly deformed.
  • the section 113 is separated from the first anti-dropping section 222 to form a gap as the first growth space 410, and the tissue passes through the anti-dropping hole 221 on the first anti-dropping section 222 into the first growth space 410 in the direction shown by the arrow in FIG. Grow to play a role of prevention.
  • the second anti-dropping section 223 and the connecting section 114 are spaced apart, and the growth space includes a second growth space 420 formed between the second anti-dropping section 223 and the connecting section 114.
  • part of the tissue passes through the anti-drop hole 221 located on the second anti-drop section 223 and enters the second growth space 420 (the arrow in FIG. 5 shows the growth direction of the tissue) ), so as to play a good fixing effect to fix the anti-displacement stent 10 in the lumen of the human body to prevent displacement.
  • the cup mouth section 110 is flexible, which not only enables the anti-displacement bracket 10 to have good compliance and reduces the impact of the anti-displacement bracket 10 on the human body, but also passes through the deformation of the cup mouth section 110.
  • the growth space is formed to allow the tissue to grow into the first growth space, thereby fixing the anti-displacement stent 10 and preventing the stent from shifting.
  • the anti-dropping portion 220 may also be spaced from the cup mouth section 110 It is provided that the first growth space 410 is formed between an end of the anti-dropping portion 220 away from the connecting portion 210 and the cup mouth section 110.
  • the connecting section 114 is a ring extending in the radial direction of the body 100.
  • the outer circumference of the ring is fixedly connected to one end of the large-diameter section 113 in the axial direction.
  • the connecting section 114 is arranged substantially perpendicular to the large-diameter section 113; the ring-shaped inner ring is fixedly connected to At one axial end of the small-diameter section 115, the connecting section 114 is arranged substantially perpendicular to the small-diameter section 115.
  • the bare frame 200 is provided with a tapered section whose radial size gradually decreases from the large-diameter section 113 to the small-diameter section 115, and the tapered section is the second anti-drop section 223.
  • the second anti-dropping section 223 is arranged at a position corresponding to the connecting section 114. Therefore, in the cross-sectional view as shown in FIG. 5, the connecting section 114, the second anti-dropping section 223 and the small diameter section 115 are enclosed to form a triangular cavity , The cavity is the second growth space 420.
  • connection between the connecting section 114 and the large-diameter section 113 is smoothly transitioned through a circular arc section
  • connection between the connecting section 114 and the small-diameter section 115 is smoothly transitioned through a circular arc section.
  • the connecting section 114 can also be provided according to requirements.
  • the connecting section 114 can be set in a truncated cone shape with a smaller taper angle than the tapered section, so that the connecting section 114 and the second anti-dropping section 223 can be spaced apart. Then, a gap as the second growth space 420 may be formed between the connecting section 114 and the second anti-drop section 223.
  • FIG. 6 is a partial structural diagram of the anti-displacement bracket 10 provided by this embodiment from a third perspective.
  • the anti-displacement bracket 10 further includes skirts 130 provided at both ends of the body 100.
  • the skirt 130 is a ring-shaped silicone mold, which is located at the end of the cup opening section 110 away from the middle section 120, and is pasted on the outer peripheral surface of the cup section 110, that is, the skirt 130 is located between the cup opening section 110 and Between the bare frames 200, the skirt 130 protrudes from the cup mouth section 110 and the bare frame 200 at the same time.
  • the skirt 130 is provided to reduce the irritation of the tissue at both ends of the anti-displacement stent 10, and prevent the tissue proliferation at the two ends of the anti-displacement stent 10 or grow from the two ends of the anti-displacement stent 10 to the anti-shift stent 10 Inside.
  • the middle section 120 of the main body 100 includes a plurality of first frame bodies 121 arranged at intervals, and two adjacent first frame bodies 121 are connected by a connecting structure.
  • the main body 100 has good compliance, so as to comply with the peristalsis of the human body lumen and reduce the impact on the human body.
  • the number of the first frame 121 is four. It is understandable that in other embodiments, the number of the first frame 121 can also be set according to the specific requirements of the overall length of the middle section 120. For example, the number of the first frame 121 is set to three or the like.
  • each first frame body 121 is a mesh structure woven with a single nickel-titanium wire.
  • the connecting structure includes a second connecting wire 122, which is a flexible wire, so as to ensure that the body 100 has good compliance.
  • the second connecting wires 122 are alternately passed between the two adjacent first frames 121 to connect the two adjacent first frames 121. Since the first frame body 121 is a mesh structure made of woven nickel-titanium wire, the second connecting wire 122 passes through the grid located at the edge of the first frame body 121 for connection.
  • the second connecting wire 122 is wound around Each grid located at the edge of one end of the first frame body 121 is arranged so as to wrap the edge of the first frame body 121 and prevent the edge of the first frame body 121 from puncturing the tissue. Understandably, the first frame body 121 is located at the two ends of the middle section 120. One end of the frame body 121 configured to be connected to the cup mouth section 110 and the bare frame 200 is wrapped by the first connecting line 230, which can prevent the tissue from being stabbed.
  • the middle section 120 further includes a second covering film 123, the second covering film 123 covers the plurality of first frame bodies 121 and the second connecting ropes arranged between two adjacent first frame bodies 121, thereby The mesh holes on the first frame body 121 and the holes formed by passing the second connecting rope back and forth are closed to prevent the tissue from passing through the middle section 120 into the interior of the anti-displacement stent 10.
  • the entire body of the anti-displacement stent 10 except for the anti-falling part 220 of the bare frame 200 is covered with a membrane, which can effectively prevent the growth of polyp tissue from entering the inside of the anti-displacement stent 10.
  • the manner of forming the second coating 123 can refer to the manner of forming the third coating 112 described above.
  • FIG. 7 is a schematic cross-sectional structure diagram of the particle capsule in the anti-displacement stent provided by this embodiment. 1 and 7 in combination, in this embodiment, the anti-displacement support 10 further includes a particle capsule 330 fixedly connected to the body 100, and the particle capsule 330 is configured to be filled with iodine particles. Specifically, the particle capsule 330 is fixed on the middle section 120 of the body 100 by thread suture. Further, a plurality of particle capsules 330 are evenly distributed on the middle section 120. When using, the doctor accurately calculates the number and position distribution of iodine particles to be carried according to the needs, such as the size of the patient’s tumor or the specific condition, etc., to form a preset plan.
  • the radioactive iodine particles are sequentially installed in the corresponding particle capsule 330 according to a preset plan, so that the iodine particles are implanted into the human body cavity along with the displacement prevention stent 10 to exert a therapeutic effect.
  • the anti-displacement bracket 10 further includes a first recovery rope 310 and a second recovery rope 320. Since the end of the bare frame 200 away from the connecting portion 210 is a free end, the main body 100 and the bare frame 200 can be individually controlled through the first recovery rope 310 and the second recovery rope 320.
  • the first recovery cord 310 is arranged on the main body 100 and can pull the main body 100 under the action of an external force to change the outer diameter of the corresponding position of the main body 100, so that the main body 100 is at the position of tissue detachment.
  • the second recovery rope 320 is arranged at the end of the anti-dropping part 220 away from the connecting part 210, and can pull the anti-dropping part 220 under the action of external force to change the outer diameter of the corresponding position of the anti-dropping part 220, so that the anti-dropping part 220 is in contact with the tissue Disengagement, so that the anti-displacement stent 10 can be recovered more easily, and damage to the tissues during the recovery process can be avoided.
  • the first recovery cord 310 is wound around the grid at the end of the cup mouth section 110 away from the middle section 120, so that by pulling the first recovery cord 310, the end of the cup mouth section 110 away from the middle section 120 shrinks and becomes smaller.
  • the tissue grown into the first growth space 410 and the second growth space 420 is separated from the cup mouth section 110.
  • the second recovery rope 320 is wound around the end of the bare frame 200 away from the connecting portion 210, that is, the second recovery rope 320 is wound around the grid at the free end of the bare frame 200, so that the bare frame 200 is pulled by the second recovery rope 320.
  • the free end of the stent shrinks and becomes smaller, so that the tissues passing through the mesh holes on the bare frame 200 into the first growth space 410 and the second growth space 420 are separated from the bare frame 200, so that the anti-displacement stent 10 can be pulled more easily. Move outside the human body to recover the anti-displacement stent 10 while avoiding tissue damage during the recovery process.
  • both ends of the anti-displacement support 10 are provided with a first recovery rope 310 and a second recovery rope 320. It should be understood that in other embodiments, the One end of the anti-displacement bracket 10 is provided with a first recovery rope 310 and a second recovery rope 320.
  • the working principle of the anti-displacement bracket 10 is as follows:
  • the iodine particles into the particle capsule 330 according to specific needs, and then implant the anti-displacement stent 10 into the lumen of the diseased part of the human body through operations such as surgery, and use the anti-displacement stent 10 to treat the narrow or obstructed part of the lumen. Support to ensure the patency of the lumen.
  • the tissue passes through the anti-drop holes 221 on the bare frame 200 (that is, the mesh holes on the bare frame 200) to the first growth space 410 and the second growth space.
  • the anti-displacement stent 10 can be fixed by the tissue located in the first growth space 410 and the second growth space 420, thereby preventing the stent from shifting.
  • the tissue in the growth space can be effectively prevented from being clamped and damaged by the cup mouth section 110 and the bare frame 200.
  • the first recovery rope 310 and the second recovery rope 320 are simultaneously pulled to recover the bracket as a whole.
  • the anti-displacement bracket 10 provided in this embodiment has at least the following advantages:
  • the embodiment of the present application provides an anti-displacement stent 10, the body 100 of which is a fully covered structure, so it can effectively prevent tissue proliferation and growth into the inside of the anti-displacement stent 10, and ensure the smooth recovery of the stent.
  • a bare frame 200 with one end connected to the middle section 120 and one end being a free end is provided outside the cup opening section 110 of the body 100.
  • a first growth space 410 and a second growth space 420 are formed between the bare frame 200 and the cup opening section 110.
  • the tissue When in use, the tissue can pass through the anti-stripping hole 221 on the bare frame 200 to enter the first growth space 410 and the second growth space 420 to grow, thereby fixing the anti-displacement stent 10, preventing the stent from shifting before being taken out, and avoiding damage
  • the human body causes secondary injury.
  • the bare frame 200 is connected to the middle section 120 through the first connecting wire 230 and the first covering film 240, and the middle section 120 is set as a plurality of first frame bodies 121 arranged at intervals, thereby ensuring that the anti-displacement stent 10 has good compliance. Sex, in order to comply with the peristalsis of the lumen.
  • the anti-displacement stent 10 provided in this embodiment can effectively prevent the tissue from being punctured and has a good use effect.
  • This embodiment also provides a method for manufacturing the anti-shift bracket to manufacture the above-mentioned anti-shift bracket.
  • the manufacturing method of the anti-displacement bracket includes:
  • S01 Set the anti-drop part of the bare frame outside the body, and connect the connecting part of the bare frame with the body.
  • a plurality of first frames are connected in series through a second connecting rope, and then the structure after the series is covered with a film to form an intermediate section with a second covering film. It is understandable that, in other embodiments, the intermediate section that has been manufactured can also be used to manufacture the anti-displacement bracket.
  • a film is applied to the second frame body to form a cup mouth section with a third film. Understandably, in other embodiments, the finished cup mouth section may also be used to manufacture the anti-displacement bracket.
  • the bare frame is sleeved outside the cup mouth section, and at this time, the anti-drop part of the bare frame is sleeved outside the cup mouth section.
  • the first connecting line is used to connect the connecting part and the end of the cup mouth section to the middle section at the same time, so that the cup mouth section and the middle section are connected to form a body, and the bare frame is also fixed on the body.
  • the connecting part of the bare frame and the area between the connecting part and the middle section are covered with a film to form a first covering film.

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Abstract

本申请的实施例提供了一种防移位支架及其制造方法，涉及医疗器械技术领域。本申请的实施例提供的防移位支架包括本体以及设置在本体外的裸架。裸架包括防脱部以及连接在防脱部一端的连接部，连接部与本体连接，从而将裸架连接在本体上。防脱部远离连接部的一端配置成与本体形成生长空间，而且防脱部上开设有多个与生长空间连通的防脱孔，因此当防移位支架植入人体管腔中后，组织通过防脱孔进入生长空间，从而在生长空间内生长，以固定防移位支架，防止支架移位，同时由于连接部设置在防脱部的一端，防脱部远离连接部的一端形成与生长空间连通的开口，从而能够获得更大的生长空间，防脱效果更好。

Description

防移位支架及其制造方法
相关申请的交叉引用
本申请要求于2019年12月26日提交中国专利局的申请号为CN201911368785.7、名称为“防移位支架及其制造方法”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，具体而言，涉及一种防移位支架及其制造方法。
背景技术
人体的管腔(例如食道或肠道等)由于各种原因和病变而引起狭窄或梗阻等疾病，目前常用的治疗方式是在狭窄或梗阻部位植入一枚支架，以保证管腔相应部位的通畅性。
然而在支架植入人体管腔后，容易产生各种并发症，其中最常见的是支架移位，支架移位后会导致原有症状的复发，因而为了保证治疗效果，需要在内镜下复位原支架或植入新支架，这无疑加重了患者的痛苦和经济负担。
因此为了防止出现支架移位这一问题，目前部分支架上进行了防移位的设计，然而现有的具有防移位设计的支架仍然存在防移位效果差的问题。
发明内容
本申请的目的包括，例如，提供了一种防移位支架，其能够改善现有技术中防移位支架防移位效果差的问题。
本申请的目的还包括，提供了一种防移位支架的制造方法，其用于制造上述的防移位支架。
本申请的实施例可以这样实现：
本申请的实施例提供了一种防移位支架，其包括本体以及位于所述本体外的裸架；所述裸架包括防脱部以及连接于所述防脱部一端的连接部；所述连接部与所述本体连接，所述防脱部配置成与所述本体形成生长空间，所述防脱部远离所述连接部的一端配置成与所述本体之间形成与所述第一生长空间连通的开口；所述防脱部具有贯穿的且与所述生长空间连通的多个防脱孔，以使组织通过所述防脱孔进入所述生长空间内。
可选地，所述防脱部与所述本体间隔设置，以形成所述生长空间。
可选地，所述本体具有柔性部，所述防脱部位于所述柔性部外，所述柔性部配置成产生形变，以使所述柔性部与所述防脱部之间形成所述生长空间。
可选地，所述防脱部呈环状，所述防脱部套设于所述本体外。
可选地，所述连接部包括多个子连接部，多个所述子连接部沿所述防脱部的周向依次设置在所述防脱部的一端。
可选地，多个所述防脱孔矩阵状分布，以形成网格结构。
可选地，所述防脱部为采用金属丝编织制成的网状结构，所述防脱孔为所述网状结构的网格孔。
可选地，所述本体包括中间段以及两个杯口段，两个所述杯口段分别设置于所述中间段的两端，且所述杯口段的径向尺寸大于所述中间段的径向尺寸；所述裸架位于所述杯口段外。
可选地，所述连接部与所述中间段连接。
可选地，所述连接部与所述中间段间隔设置；所述防移位支架还包括第一连接线，所述连接部通过所述第一连接线与所述中间段固定连接。
可选地，所述防移位支架还包括设置在所述连接部与所述中间段外的第一覆膜，所述第一覆膜的两端分别与所述连接部和所述中间段固定连接。
可选地，所述杯口段包括大径段、连接段以及小径段，所述大径段的径向尺寸大于所述中间段的径向尺寸；所述连接段的两端分别与所述大径段和所述小径段固定连接，所述小径段与所述中间段连接；所述裸架从所述大径段外延伸至所述小径段外。
可选地，所述生长空间包括第一生长空间；所述裸架与所述大径段之间配置成形成所述第一生长空间。
可选地，所述生长空间还包括第二生长空间；所述裸架与所述连接段间隔设置，以在所述裸架和所述连接段之间形成所述第二生长空间。
可选地，所述中间段包括多个间隔设置的第一架体，相邻所述第一架体之间通过连接结构连接。
可选地，所述连接结构包括第二连接线，相邻两个所述第一架体通过所述第二连接线连接。
可选地，所述中间段还包括设置在所述连接结构和多个所述第一架体上的第二覆膜。
可选地，所述杯口段包括第二架体以及设置在所述第二架体上的第三覆膜，所述裸架位于所述第二架体外。
可选地，所述防移位支架还包括设置在所述本体两端的裙边。
可选地，所述防移位支架还包括固定在所述本体上的粒子囊，所述粒子囊配置成填装碘粒子。
可选地，所述防移位支架还包括第一回收绳以及第二回收绳；所述第一回收绳设置于所述本体，且配置成在外力的作用下拉动所述本体，以改变所述本体的外径；所述第二回收绳设置在所述防脱部远离所述连接部的一端，且配置成在外力的作用下拉动所述防脱部，以改变所述防脱部的外径。
本申请的实施例还提供了一种防移位支架的制造方法。该方法用于制造上述的防移位支架。防移位支架的制造方法包括：将所述裸架的防脱部设置在所述本体外，并将所述裸架的连接部与所述本体连接。
可选地，所述将所述裸架的防脱部设置在所述本体外，并将所述裸架的连接部与所述本体连接的步骤包括：
将所述防脱部套设在所述本体的杯口段；采用第一连接线将所述连接部以及所述杯口段的端部同时与所述本体的中间段连接；对所述连接部以及所述连接部至所述中间段的区域进行覆膜。
本申请实施例的防移位支架及其制造方法的有益效果包括，例如：
本申请的实施例提供了一种防移位支架，其包括本体以及设置在本体外的裸架。裸架包括防脱部以及连接在防脱部一端的连接部，连接部与本体连接，从而将裸架连接在本体上。防脱部配置成与本体形成生长空间，而且防脱部上设置有多个与生长空间连通的防脱孔，因此当防移位支架植入人体管腔中后，人体管腔的组织通过防脱孔进入生长空间，从而在生长空间内生长，以固定防移位支架，防止支架移位，同时由于连接部设置在防脱部的一端，防脱部远离连接部的一端形成与生长空间连通的开口，从而能够获得更大的生长 空间，防脱效果更好。
本申请的实施例还提供了一种防移位支架的制造方法，该制造方法用于制造上述的防移位支架。
附图说明
为了更清楚地说明本申请实施例的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，应当理解，以下附图仅示出了本申请的某些实施例，因此不应被看作是对范围的限定，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他相关的附图。
图1为本申请实施例提供的防移位支架在第一视角下的整体结构示意图；
图2为图1中Ⅱ处的局部结构放大示意图；
图3为本申请实施例提供的防移位支架在第二视角下的局部结构示意图；
图4为本申请实施例提供的另一种防移位支架的局部结构示意图；
图5为本申请实施例提供的防移位支架中杯口段处的剖面结构示意图；
图6为本申请实施例提供的防移位支架在第三视角下的局部结构示意图；
图7为本申请实施例提供的防移位支架中粒子囊的剖面结构示意图。
图标：10-防移位支架；100-本体；110-杯口段；111-第二架体；112-第三覆膜；113-大径段；114-连接段；115-小径段；116-第二子连接部；120-中间段；121-第一架体；122-第二连接线；123-第二覆膜；130-裙边；200-裸架；210-连接部；211-第一子连接部；220-防脱部；221-防脱孔；222-第一防脱段；223-第二防脱段；230-第一连接线；240-第一覆膜；310-第一回收绳；320-第二回收绳；330-粒子囊；410-第一生长空间；420-第二生长空间。
具体实施方式
为使本申请实施例的目的、技术方案和优点更加清楚，下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚和完整地描述，显然，所描述的实施例是本申请一部分实施例，而不是全部的实施例。通常在此处附图中描述和示出的本申请实施例的组件可以以各种不同的配置来布置和设计。
因此，以下对在附图中提供的本申请的实施例的详细描述并非旨在限制要求保护的本 申请的范围，而是仅仅表示本申请的选定实施例。基于本申请中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
应注意到：相似的标号和字母在下面的附图中表示类似项，因此，一旦某一项在一个附图中被定义，则在随后的附图中不需要对其进行进一步定义和解释。
在本申请的描述中，需要说明的是，若出现术语“上”、“下”、“内”或“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，或者是该发明产品使用时惯常摆放的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位或者必须以特定的方位构造和操作，因此不能理解为对本申请的限制。
此外，若出现术语“第一”和“第二”等仅用于区分描述，而不能理解为指示或暗示相对重要性。
需要说明的是，在不冲突的情况下，本申请的实施例中的特征可以相互结合。
图1为本实施例提供的防移位支架10在第一视角下的整体结构示意图，图2为图1中Ⅱ处的局部结构放大示意图。请结合参考图1和图2，本实施例提供了一种防移位支架10，其包括本体100以及设置在本体100外的裸架200。裸架200包括防脱部220以及连接在防脱部220一端的连接部210，连接部210与本体100连接，从而将裸架200连接在本体100上。防脱部220配置成与本体100形成生长空间，而且防脱部220上形成有与生长空间连通的多个防脱孔221，因此当防移位支架10植入人体管腔(例如食道或肠道等)中后，人体管腔的组织(例如，将支架伸入人体的食道，则，该组织为人体食道内壁处的组织)会接触防脱部220，并且部分组织会通过防脱孔221进入生长空间，并且在生长空间内生长，以固定防移位支架10进行定位，防止支架移位，同时由于连接部210设置在防脱部220的一端，因此裸架200仅一端与本体100连接，另一端形成自由端，防脱部220远离连接部210的一端形成与生长空间连通的开口，从而能够获得更大的生长空间，防脱效果更好。
下面对本实施例提供的防移位支架10进行进一步说明：
请参照图1，在本实施例中，本体100包括中间段120以及两个杯口段110，两个杯口段110分别为第一杯口段和第二杯口段。中间段120、第一杯口段和第二杯口段均为圆管 状，第一杯口段和第二杯口段分别设置在中间段120轴向的两端，同时第一杯口段和第二杯口段的径向尺寸大于中间段120的径向尺寸，从而形成哑铃状的本体100。具体地，杯口段110的长度为a，14mm≤a≤16mm，第一杯口段和第二杯口段之间的长度根据病变部位的大小具体设置，在本实施例中，第一杯口段和第二杯口段之间的长度为b，40mm≤b≤150mm。可选地，a＝14mm、15mm或16mm；b＝40mm、100mm或150mm。
请参照图2，杯口段110包括第二架体111以及覆着在第二架体111上的第三覆膜112，因此第二架体111的外形特征即为杯口段110的外形特征。第二架体111为采用单根镍钛丝编织而成的网状筒体，通过在第二架体111上覆膜，以形成第三覆膜112，从而将第二架体111上的网格孔封闭，防止防移位支架10放入人体管腔中后，组织穿过第二架体111上的网格孔进入防移位支架10内部。第三覆膜112的形成方式可选地，通过将第二架体111浸入液态的硅胶中，待液态的材料将所有的网格孔覆盖后，取出第二架体111，冷却后形成包覆有第三覆膜112的第二架体111。
裸架200包括防脱部220以及连接在防脱部220一端的连接部210，连接部210与本体100连接，从而将防脱部220连接在本体100上。在本实施例中，防脱部220位于杯口段110外，连接部210与中间段120的端部连接，防脱部220远离连接部210的一端形成自由端。具体地，裸架200的数量为两个，两个裸架200分别设置在第一杯口段和第二杯口段外，且两个裸架200的连接部210分别与中间段120轴向的两个端部连接。防脱部220与杯口段110之间形成生长空间，防脱部220上设置有多个与生长空间连通的防脱孔221。由于构成杯口段110的第二架体111上覆着有第三覆膜112，因此从防脱孔221内进入第一生长空间410的组织由于第三覆膜112的阻挡无法穿过第二架体111继续生长进入杯口段110内侧，从而避免了造成再次狭窄，同时保证了人体管腔病变部位痊愈后能够顺利将防移位支架10回收。
通过将裸架200设置在杯口段110外，使得防移位支架10的杯口段110形成双层结构，中间段120为单层结构，由于杯口段110的长度较小，因此将裸架200设置在杯口段110外后，不仅能够获得良好的防移位效果，而且防移位支架10对人体管腔狭窄部位组织的影响小。该结构可以在发挥防移位功能的同时，避免对防移位支架10整体的力学性能造成影响，进而避免由于支架支撑力过大而压迫管腔内狭窄部位组织进而造成组织坏死和穿孔的问题。可以理解地，在其他实施例中，也可以根据需求具体设置裸架200的位置。
进一步地，裸架200整体为环状，即防脱部220和连接部210均为环状，防脱部220 套设在杯口段110上，从而使防脱部220远离连接部210的一端与杯口段110之间形成环状的生长空间，沿杯口段110的周向，组织可均匀地生长进入生长空间，防脱效果更好。
在本实施例中，裸架200上的多个防脱孔221呈矩阵状分布，从而形成网格结构，以使组织通过防脱孔221均匀进入第一生长空间410。进一步地，裸架200为采用金属丝编织制成的网状结构，即防脱部220为采用金属丝编织制成的网状结构，防脱孔221为该网状结构上相邻金属丝之间形成的网格孔。需要说明的，在本实施例中，防脱孔221为菱形的网格孔，可以理解地，在其他实施例中，也可以根据需求具体设置防脱孔221的形状，例如将防脱孔221设置为圆形、长条形或者三角形等，能够通过防脱孔221使得组织进入生长空间即可。
可选地，裸架200采用单根金属丝编织制成，连接部210为金属丝形成在裸架200端部的多个凸出网格，每个凸出网格形成一个子连接部，该子连接部为第一子连接部211，多个第一子连接部211沿防脱部220的周向依次设置在防脱部220的一端。可选地，金属丝的材质为镍钛合金。可以理解地，在其他实施例中，也可以根据需求选用其他材质制成裸架200。
图3为本实施例提供的防移位支架10在第二视角下的局部结构示意图。请参照图3，由于第二架体111为采用单根镍钛丝编织而成的网状结构，网状结构的端部也形成有多个凸出网格，每一凸出网格形成一个子连接部，该子连接部为第二子连接部116。在本实施例中，防移位支架10还包括第一连接线230，连接部210与中间段120通过第一连接线230连接。具体地，第二子连接部116和第一子连接部211对应设置，即形成第一子连接部211的网格与形成第二子连接部116的网格重叠，在第一连接线230将连接部210与中间段120连接的过程中，第一连接线230穿过中间段120后同时绕过第一子连接部211和第二子连接部116然后再穿过中间段120设置，第一连接线230沿本体100的周向在中间段120以及第一子连接部211和第二子连接部116的重叠位置交替绕设，从而将裸架200以及杯口段110与中间段120连接。可选地，第一连接线230为软线，以使连接处呈软态，使得防移位支架10能够更好地顺应人体管腔的蠕动。
第一子连接部211和第二子连接部116一一对应设置，每一第二子连接部116均与对应的第一子连接部211重叠设置。进一步地，第一连接线230绕过每一第一连接部210和第二子连接部116设置，如此通过第一连接线230对裸架200末端包裹，避免裸架200末端刺伤组织或对人体造成损伤。
进一步地，防移位支架10还包括设置在连接部210与中间段120外的第一覆膜240，覆膜的两端分别与连接部210和中间段120固定连接。通过设置第一覆膜240将第一连接线230来回绕设产生的孔洞封闭，防止组织穿过该孔洞向防移位支架10内部生长。同时第一覆膜240延伸覆盖至形成第一子连接部211的网格，因此裸架200靠近中间段120一端的端部被第一覆膜240覆盖，进一步避免裸架200末端刺伤组织或对人体造成损伤。相应地，第一覆膜240的形成方式可以参照上述的第三覆膜112的形成方式。
需要说明的，在本实施例中，通过设置第一覆膜240以及将第一连接绳设置为绕过每一第一子连接部211，从而避免裸架200端部刺伤组织，可以理解地，在其他实施例中，也可以根据需求具体设置，例如图4所示，将第一连接绳设置为间隔绕设第一子连接部211。
图5为本实施例提供的防移位支架10中杯口段110处的剖面结构示意图，且在该剖面图中仅对裸架200进行剖切。请参照图5，在本实施例中，第二架体111包括依次设置的大径段113、连接段114和小径段115，大径段113、连接段114和小径段115通过镍钛金属丝编织一体成型。第二架体111的第二子连接部116形成在小径段115远离大径段113的一端，连接段114的两端分别与大径段113和小径段115固定连接。大径段113和小径段115均为圆筒状结构，显然地，大径段113的径向尺寸大于小径段115的径向尺寸。小径段115的径向尺寸与中间段120的径向尺寸相同，大径段113的径向尺寸大于中间段120的径向尺寸。
裸架200套设在杯口段110外，且裸架200远离连接部210的一端位于大径段113外，裸架200的连接部210沿轴向延伸覆盖连接段114后与位于小径段115的第二子连接部116重合。进一步地，裸架200与连接段114间隔设置，从而在裸架200与连接段114之间形成缝隙。
具体地，防脱部220包括相互连接的第一防脱段222和第二防脱段223。第一防脱段222包覆在大径段113外，生长空间包括形成于第一防脱段222和大径段113之间的第一生长空间410。由于杯口段110通过在采用单根镍钛丝编织而成的第二架体111上覆着第三覆膜112制成，因此大径段113不仅能够支撑人体管腔的狭窄部位，而且具有一定的柔性，形成本体100的柔性部，因此组织在穿过防脱孔221向大径段113生长的过程中，组织抵触大径段113，使得大径段113发生轻微形变，以使大径段113与第一防脱段222分隔形成作为第一生长空间410的间隙，组织如图2中箭头所示方向穿过第一防脱段222上的防脱孔221向第一生长空间410内生长，以发挥防脱作用。第二防脱段223与连接段114间隔 设置，生长空间包括形成于第二防脱段223与连接段114之间的第二生长空间420。防移位支架10植入人体管腔中后，部分组织穿过位于第二防脱段223上的防脱孔221进入第二生长空间420(如图5中的箭头所示为组织的生长方向)，从而起到良好的固定作用，以将防移位支架10固定在人体管腔中，防止移位。
需要说明的，在本实施例中，杯口段110具有柔性，不仅使得防移位支架10能够具有良好的顺应性，减少防移位支架10对人体的影响，而且通过杯口段110的形变形成生长空间，以使组织生长进入第一生长空间，从而固定防移位支架10，防止支架移位，可以理解地，在其他实施例中，也可以将防脱部220与杯口段110间隔设置，防脱部220远离连接部210的一端与杯口段110之间形成作为该第一生长空间410的间隙。
连接段114为沿本体100的径向延伸的环形，该环形的外周固定连接在大径段113轴向的一个端部，连接段114大致垂直大径段113设置；环形的内圈固定连接在小径段115轴向的一个端部，连接段114大致垂直小径段115设置。裸架200上设置有从大径段113指向小径段115的方向径向尺寸逐渐减小的锥形段，该锥形段即为第二防脱段223。第二防脱段223设置在与连接段114对应位置处，因此在如图5所示的剖面图中，连接段114、第二防脱段223和小径段115围设形成呈三角形的空腔，该空腔即为第二生长空间420。进一步地，连接段114与大径段113的连接处通过圆弧段圆滑过渡，连接段114与小径段115的连接处通过圆弧段圆滑过渡。
可以理解地，在其他实施例中，也可以根据需求设置连接段114，例如将连接段114设置为锥角小于锥形段的圆锥台形，能够使连接段114与第二防脱段223间隔设置，进而在连接段114与第二防脱段223之间形成作为第二生长空间420的缝隙即可。
图6为本实施例提供的防移位支架10在第三视角下的局部结构示意图。请参照图6，在本实施例中，防移位支架10还包括设置在本体100两端的裙边130。具体地，裙边130为环状的硅胶模，其位于杯口段110远离中间段120一端的端部，且粘贴在杯口段110的外周面上，即裙边130位于杯口段110与裸架200之间，同时裙边130凸出杯口段110和裸架200设置。通过设置裙边130，从而减小防移位支架10两侧端部对组织的刺激，防止防移位支架10两端的组织增生或从防移位支架10的两端生长到防移位支架10内。
请参照图1，在本实施例中，本体100的中间段120包括多个间隔设置的第一架体121，相邻两个第一架体121之间通过连接结构连接。通过将中间段120设置为多个间隔的第一架体121，从而使得本体100具有良好的顺应性，以顺应人体管腔的蠕动，减轻对人体的 影响。具体地，在本实施例中，第一架体121的数量为四个，可以理解地，在其他实施例中，也可以根据中间段120整体长度的具体需求设置第一架体121的数量，例如将第一架体121的数量设置为三个等。可选地，每一第一架体121为采用单根镍钛丝编织而成的网状结构。
进一步地，连接结构包括第二连接线122，第二连接线122为软线，从而保证本体100具有良好的顺应性。第二连接线122在相邻的两个第一架体121之间交替穿设，从而将相邻两个第一架体121连接。由于第一架体121为镍钛丝编织制成的网状结构，因此第二连接线122依次穿过位于第一架体121边缘的网格进行连接，可选地，第二连接线122绕过位于第一架体121一端边缘的每一网格设置，从而包裹第一架体121的边缘，防止第一架体121的边缘刺伤组织，可以理解地，位于中间段120两端的第一架体121中配置成与杯口段110和裸架200连接的一端通过第一连接线230包裹，即可防止刺伤组织。
进一步地，中间段120还包括第二覆膜123，第二覆膜123覆着在多个第一架体121和设置在相邻两个第一架体121之间的第二连接绳，从而将第一架体121上的网格孔以及第二连接绳来回穿设形成的孔洞封闭，防止组织穿过中间段120进入防移位支架10内部。如此，防移位支架10整体除裸架200的防脱部220外全覆膜，能够有效防止息肉组织生长进入防移位支架10内部。相应地，第二覆膜123的形成方式可以参照上述的第三覆膜112的形成方式。
图7为本实施例提供的防移位支架中粒子囊的剖面结构示意图。请结合参照图1和图7，在本实施例中，防移位支架10还包括固定连接在本体100上的粒子囊330，粒子囊330配置成填装碘粒子。具体地，粒子囊330采用线缝合固定在本体100的中间段120上。进一步地，多个粒子囊330均匀分布在中间段120上，使用时，医生根据需求，例如患者肿瘤大小或具体病情等，精确计算需要携带碘粒子数量和位置分布等形成预设方案，并在手术过程中将放射性碘粒子按预设方案依次安装在对应的粒子囊330中，从而使碘粒子随防移位支架10植入人体管腔中，发挥治疗作用。
请参照图2，在本实施例中，防移位支架10还包括第一回收绳310和第二回收绳320。由于裸架200远离连接部210的一端为自由端，因此通过第一回收绳310和第二回收绳320可对本体100以及裸架200进行单独控制。第一回收绳310设置在本体100上，且能够在外力作用下拉动本体100，以改变本体100对应位置处的外径，使得本体100该位置处于组织脱离。第二回收绳320设置在防脱部220远离连接部210的一端，且能够在外力作用 下拉动防脱部220，以改变防脱部220对应位置处的外径，使得防脱部220与组织脱离，从而能够更加轻易地对防移位支架10进行回收，且避免在回收过程中对组织造成损伤。
具体地，第一回收绳310绕设在杯口段110远离中间段120一端端部的网格，从而通过拉动第一回收绳310使得杯口段110远离中间段120的一端收缩变小，进而使生长进入第一生长空间410和第二生长空间420内的组织与杯口段110脱离。第二回收绳320绕设在裸架200远离连接部210的一端，即第二回收绳320绕设在裸架200的自由端处的网格，从而通过拉动第二回收绳320使得裸架200的自由端收缩变小，进而使穿过裸架200上的网格孔进入第一生长空间410和第二生长空间420内的组织与裸架200脱离，从而更加轻易地拉动防移位支架10向人体外运动，进而将防移位支架10回收，同时在回收过程中避免损伤组织。
需要说明的，在本实施例中，防移位支架10的两端均设置有第一回收绳310和第二回收绳320，可以理解地，在其他实施例中，也可以根据需求，仅在防移位支架10的一端设置第一回收绳310和第二回收绳320。
根据本实施例提供的一种防移位支架10，防移位支架10的工作原理：
首先根据具体需求依次将碘粒子放入粒子囊330中，然后通过手术等操作将防移位支架10植入人体病变部位的管腔中，通过防移位支架10对管腔的狭窄或梗阻部位进行支撑，保证管腔的通畅性。随着防移位支架10进入人体管腔中的时间增长，组织穿过裸架200上的防脱孔221(即裸架200上的网格孔)向第一生长空间410和第二生长空间420内生长，待管腔经过治疗肿瘤逐渐消退或狭窄逐渐减轻后，能够通过位于第一生长空间410和第二生长空间420内的组织对防移位支架10固定，从而防止支架移位。
治疗结束后，首先拉动第一回收绳310，使杯口段110收缩，且与组织分离，然后拉动第二回收绳320，使穿过裸架200生长的组织松动，并最终与裸架200脱离，组织对裸架200的抓紧力消失，同时由于在拉动第二回收绳320前通过拉动第一回收绳310使组织与杯口段110分离，因此在拉动第二回收绳320使组织与裸架200脱离的过程中能够有效防止生长空间内的组织受到杯口段110和裸架200的夹持而受损。最后同时拉动第一回收绳310和第二回收绳320将支架整体回收。
本实施例提供的一种防移位支架10至少具有以下优点：
本申请的实施例提供了一种防移位支架10，其本体100为全覆膜结构，因此能够有效 防止组织增生生长到防移位支架10内部，保证支架的顺利回收。同时在本体100的杯口段110外设置有一端与中间段120连接，一端为自由端的裸架200，裸架200与杯口段110之间形成有第一生长空间410和第二生长空间420，使用时组织可穿过裸架200上的防脱孔221进入第一生长空间410和第二生长空间420生长，从而固定防移位支架10，防止支架在取出前发生移位，进而避免对人体造成二次伤害。裸架200通过第一连接线230和第一覆膜240与中间段120连接，同时中间段120设置为多个间隔设置的第一架体121，从而保证了防移位支架10具有良好的顺应性，以顺应管腔的蠕动。而且本实施例提供的防移位支架10能够有效防止刺伤组织，使用效果好。
本实施例还提供了一种防移位支架的制造方法，以制造上述的防移位支架。具体地，防移位支架的制造方法包括：
S01：将裸架的防脱部设置在本体外，并将裸架的连接部与本体连接。
将多个第一架体通过第二连接绳串联，然后对串联后的结构进行覆膜，以形成具有第二覆膜的中间段。可以理解地，在其他实施例中，也可以采用已经制作完成的中间段制造防移位支架。
在第二架体上进行覆膜，以形成具有第三覆膜的杯口段。可以理解地，在其他实施例中，也可以采用已经制作完成的杯口段制造防移位支架。
将裸架套设在杯口段外，此时裸架的防脱部套设在杯口段外。采用第一连接线将连接部以及杯口段的端部同时与中间段连接，从而使得杯口段与中间段连接形成本体，同时裸架也固定在本体上。最后对裸架的连接部，以及位于连接部与中间段之间的区域进行覆膜，以形成第一覆膜。
以上所述，仅为本申请的具体实施方式，但本申请的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本申请揭露的技术范围内，可轻易想到的变化或替换，都应涵盖在本申请的保护范围之内。因此，本申请的保护范围应以所述权利要求的保护范围为准。

Claims (21)

  1. 一种防移位支架，其特征在于，包括本体以及位于所述本体外的裸架；所述裸架包括防脱部以及连接于所述防脱部一端的连接部；所述连接部与所述本体连接，所述防脱部配置成与所述本体形成生长空间，所述防脱部远离所述连接部的一端配置成与所述本体之间形成与所述生长空间连通的开口；所述防脱部具有贯穿的且与所述生长空间连通的多个防脱孔，以使组织通过所述防脱孔进入所述生长空间内。
  2. 根据权利要求1所述的防移位支架，其特征在于，所述防脱部与所述本体间隔设置，以形成所述生长空间。
  3. 根据权利要求1所述的防移位支架，其特征在于，所述本体具有柔性部，所述防脱部位于所述柔性部外，所述柔性部配置成产生形变，以使所述柔性部与所述防脱部之间形成所述生长空间。
  4. 根据权利要求1所述的防移位支架，其特征在于，所述防脱部呈环状，所述防脱部套设于所述本体外。
  5. 根据权利要求4所述的防移位支架，其特征在于，所述连接部包括多个子连接部，多个所述子连接部沿所述防脱部的周向依次设置在所述防脱部的一端。
  6. 根据权利要求1所述的防移位支架，其特征在于，所述本体包括中间段以及两个杯口段，两个所述杯口段分别设置于所述中间段的两端，且所述杯口段的径向尺寸大于所述中间段的径向尺寸；所述裸架位于所述杯口段外。
  7. 根据权利要求6所述的防移位支架，其特征在于，所述连接部与所述中间段连接。
  8. 根据权利要求7所述的防移位支架，其特征在于，所述连接部与所述中间段间隔设置；所述防移位支架还包括第一连接线，所述连接部通过所述第一连接线与所述中间段固定连接。
  9. 根据权利要求7所述的防移位支架，其特征在于，所述防移位支架还包括设置在所述连接部与所述中间段外的第一覆膜，所述第一覆膜的两端分别与所述连接部和所述中间段固定连接。
  10. 根据权利要求6所述的防移位支架，其特征在于，所述杯口段包括大径段、连接段以及小径段，所述大径段的径向尺寸大于所述中间段的径向尺寸；所述连接段的两端分别与所述大径段和所述小径段固定连接，所述小径段与所述中间段连接；所述裸架从所述大径段外延伸至所述小径段外。
  11. 根据权利要求10所述的防移位支架，其特征在于，所述生长空间包括第一生长空间；所述裸架与所述大径段之间配置成形成所述第一生长空间。
  12. 根据权利要求10所述的防移位支架，其特征在于，所述生长空间还包括第二生长空间；所述裸架与所述连接段间隔设置，以在所述裸架和所述连接段之间形成所述第二生长空间。
  13. 根据权利要求6所述的防移位支架，其特征在于，所述中间段包括多个间隔设置的第一架体，相邻所述第一架体之间通过连接结构连接。
  14. 根据权利要求13所述的防移位支架，其特征在于，所述连接结构包括第二连接线，相邻两个所述第一架体通过所述第二连接线连接。
  15. 根据权利要求13所述的防移位支架，其特征在于，所述中间段还包括设置在所述连接结构和多个所述第一架体上的第二覆膜。
  16. 根据权利要求6所述的防移位支架，其特征在于，所述杯口段包括第二架体以及设置在所述第二架体上的第三覆膜，所述裸架位于所述第二架体外。
  17. 根据权利要求1所述的防移位支架，其特征在于，所述防移位支架还包括设置在所述本体两端的裙边。
  18. 根据权利要求1所述的防移位支架，其特征在于，所述防移位支架还包括固定在所述本体上的粒子囊，所述粒子囊配置成填装碘粒子。
  19. 根据权利要求1-18任一项所述的防移位支架，其特征在于，所述防移位支架还包括第一回收绳以及第二回收绳；所述第一回收绳设置于所述本体，且配置成在外力的作用下拉动所述本体，以改变所述本体的外径；所述第二回收绳设置在所述防脱部远离所述连接部的一端，且配置成在外力的作用下拉动所述防脱部，以改变所述防脱部的外径。
  20. 一种防移位支架的制造方法，用于制造如权利要求1-19任一项所述的防移位支架，其特征在于，包括：
    将所述裸架的防脱部设置在所述本体外，并将所述裸架的连接部与所述本体连接。
  21. 根据权利要求20所述的防移位支架的制造方法，其特征在于，所述将所述裸架的防脱部设置在所述本体外，并将所述裸架的连接部与所述本体连接的步骤包括：
    将所述防脱部套设在所述本体的杯口段；采用第一连接线将所述连接部以及所述杯口段的端部同时与所述本体的中间段连接；对所述连接部以及所述连接部至所述中间段的区域进行覆膜。
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